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510(k) Data Aggregation

    K Number
    K061758
    Device Name
    ACTIVE RENIN IRMA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2006-07-28

    (36 days)

    Product Code
    CIB
    Regulation Number
    862.1085
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K020945
    Device Name
    AXSYM INTACT PTH, MODEL 2G06
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2002-05-31

    (67 days)

    Product Code
    CEW, JIT, JIX
    Regulation Number
    862.1545
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
    Device Description
    AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
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    K Number
    K020128
    Device Name
    ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2002-03-01

    (45 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL-10-8500 ACTIVE™ Free 3-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.
    Device Description
    The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample.
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    K Number
    K002128
    Device Name
    ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2000-12-05

    (144 days)

    Product Code
    NDR
    Regulation Number
    862.1260
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001086
    Device Name
    FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2000-05-18

    (44 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990138
    Device Name
    DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1999-06-21

    (153 days)

    Product Code
    LOJ
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL 10-8400 AFP ELISA assay is intended for the quantitative determination of AFP in human serum. It is intended for in vitro diagnostic use to aid in the management of patients with nonseminomatous testicular cancer.
    Device Description
    The DSL-10-8400 ACTIVE™ AFP ELISA is an enzymatically amplified "two-step" sandwichtype immunoassay. In the assay, Standards, Controls and unknown serum samples are incubated in microtitration wells which have been coated with anti-AFP antibody. After incubation and washing, the wells are treated with another anti-AFP detection antibody labelled with the enzyme horseradish peroxidase (HRP). After a second incubation and washing step, the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement at 450 and 620 nm. The absorbance measured is directly proportional to the concentration of AFP present. A set of AFP Standards is used to plot a standard curve of absorbance versus AFP concentration from which the AFP concentrations in the unknowns can be calculated.
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    K Number
    K981871
    Device Name
    C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1998-11-09

    (165 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
    Device Description
    The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
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    K Number
    K973243
    Device Name
    ACTIVE PSA ELISA (DSL-10-9700)
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1998-08-03

    (339 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
    Device Description
    The DSL 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the microtiter plate wells, the other antibody is conjugated the the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
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    K Number
    K973244
    Device Name
    ACTIVE PSA IRMA (DSL-9700)
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1998-08-03

    (339 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
    Device Description
    The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
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    K Number
    K981607
    Device Name
    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1998-05-27

    (22 days)

    Product Code
    CIB
    Regulation Number
    862.1085
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC SYSTEMS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
    Device Description
    The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.
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